Approved Biologic Therapies in Rheumatoid Arthritis Show Further Evidence of Efficacy and Reduction in Joint Damage at the 2011

Conference highlights include emerging predictive biomarkers, life cycle management and label expansion trials for approved biologics, along with results for Pfizer's novel oral drug for rheumatoid arthritis.

NEW YORK, June 8, 2011 /PRNewswire/ -- One of the major annual rheumatology conferences, the European League Against Rheumatism's Congress (EULAR), was held May 25-28 in London.  Citeline, Inc., reviewed the trends and highlights from clinical trial results reported at EULAR, noting that approved biologics in rheumatoid arthritis dominated the program, comprising roughly 25% of clinical trial abstracts presented.  

Updates from long-term trials for approved biologics in RA—including adalimumab, etanercept, abatacept, rituximab and tocilizumab—provided further evidence of sustained clinical efficacy by standard measures, but also extended to reductions in joint damage (by radiographic and MRI methodologies), remission induction and effective treatment of early disease.  Of these approved biologics, tocilizumab trial results were the most numerous, and included several reports of treatment impact on serum lipid levels and other cardiovascular-related outcomes.  

Citeline's Senior Analyst in Autoimmune/Inflammation, Claire Herman, noted that the industry-wide interest in personalized medicine was evident at EULAR, with an array of abstracts presenting results from studies aimed at identifying biomarkers and pharmacogenomic markers as predictors of response to specific approved biologics. "This research is indicative of companies' focus on carving out individual niches within this highly competitive chronic disease arena," remarks Ms. Herman.  

Additionally, a number of these approved drugs' sponsors continue to focus on life-cycle management and expanded labeling, as evidenced by abstracts reporting results from trials of the subcutaneous formulation of abatacept (ALLOW and ACQUIRE), pivotal trials for Japanese approval of golimumab for RA, tocilizumab juvenile RA studies (TENDER), and rituximab combination therapies results.

Novel therapeutics in RA were also showcased at EULAR. Citeline's Associate Director of Autoimmune/Inflammation, Dr. Laura Runkel, found several presentations from Pfizer to be most notable. Pfizer presented results from its ORAL Sync pivotal trial investigating tofacitinib in combination with traditional DMARDs, as well as data from its ORAL Solo trial, evaluating the oral JAK3 kinase inhibitor as monotherapy.  With the presentation of these results, Pfizer has now shared top-line data for all four of its tofacitinib pivotal trials.

"The company has announced plans to file for FDA and EMEA approval in a wide range of treatment combinations and patient populations by the end of 2011, representing the first filing for a biotechnology-derived, targeted oral treatment for RA," comments Dr. Runkel. "If the filings occur as planned, they will put tofacitinib far ahead of its closest competitor, Rigel/AstraZeneca's fostamatinib, whose syk kinase inhibitor is projected to complete pivotal trials in 2013."

About Citeline

Citeline (www.citeline.com) provides the world's most comprehensive real-time R&D intelligence to the pharmaceutical industry, covering global clinical trial, investigator and drug intelligence. Our data is drawn from over 18,000 unique sources and analyzed by the industry's largest team – over 250 full-time expert analysts and editors.

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SOURCE Citeline